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Completed NCT07713225

Preparation Methods on PFT Performance

Conditions: Fear Anxiety, Pulmonary, Performance Assessment

Sex: All
Ages: 6 Years – 12 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 96
Sponsor: Selcuk University

Location: Selcuk University Konya Türkiye

Summary

Background: Successful spirometry in children depends on adequate cooperation and correct performance of respiratory maneuvers. Although several preparation strategies have been proposed, evidence comparing their effects on both spirometry performance and procedure-related fear remains limited. This study compared the effects of routine verbal instruction, verbal instruction with demonstration, and animation-assisted preparation on pulmonary function test (PFT) performance and procedure-related fear in children undergoing spirometry. Methods: This three-arm randomized controlled trial was conducted in the Pediatric Pulmonary Function Test Unit of a tertiary children's allergy and immunology outpatient clinic. Ninety-six children aged 6-12 years referred for spirometry were allocated using stratified randomization to routine verbal instruction (control, n = 32), verbal instruction with demonstration (n = 32), or animation-assisted preparation (n = 32). Data were collected using Descriptive Characteristics Form, Pulmonary Function Test Parameters Form, and Children's Fear Scale (CFS). Pulmonary function parameters were recorded during the first three acceptable spirometry maneuvers, and procedure-related fear was assessed immediately before and after testing.

Eligibility Criteria

Inclusion Criteria: * Children were eligible for inclusion if they were 6-12 years of age and had no cognitive, visual, or hearing impairments that could interfere with understanding or performing the spirometry procedure. Exclusion Criteria: * Children were excluded if they were unable to understand or communicate in Turkish, had communication difficulties, declined to participate, had conditions that could interfere with spirometry performance (e.g., cleft lip, cleft palate, jaw anomalies, or oral/dental problems preventing an adequate seal around the mouthpiece), or had previously viewed or used the Fish Animation employed in the animation-assisted preparation to avoid familiarity and learning effects. Withdrawn criteria: \- Participants were withdrawn from the study if they completed fewer than three acceptable spirometry maneuvers, discontinued the procedure before completion, or requested to withdraw during testing.

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Source: ClinicalTrials.gov (NCT07713225). StuddyBuddy aggregates publicly available trial information.